To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

48

Study Start Date:

February 2005

Study Completion Date:

January 2008

Primary Completion Date:

June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Mifepristone

200mg orally once daily

Other Name: RU-486

Detailed Description:

Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

Currently active second malignancy other than non-melanoma skin cancer

Baseline adrenal insufficiency requiring long-term steroids

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140478